Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis.

BACKGROUND: Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic pain. Thus being, many patients seek help in complementary and alternative medicine, including homeopathy. The effectiveness of homeopathic treatment for endometriosis is controversial due to the lack of evidences in the literature. The aim of the present randomized controlled trial is to assess the efficacy of potentized estrogen compared to placebo in the treatment of chronic pelvic pain associated with endometriosis. METHODS/DESIGN: The present is a randomized, double-blind, placebo-controlled trial of a homeopathic medicine individualized according to program 'New Homeopathic Medicines: use of modern drugs according to the principle of similitude' (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to the adverse events caused by estrogen were recruited at the Endometriosis Unit of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP). The participants were selected based on the analysis of their medical records and the application of self-report structured questionnaires. A total of 50 women meeting the eligibility criteria will be randomly allocated to receive potentized estrogen or placebo. The primary clinical outcome measure will be severity of chronic pelvic pain. Statistical analysis will be performed on the intention-to-treat and per-protocol approaches comparing the effect of the homeopathic medicine versus placebo after 24 weeks of intervention. DISCUSSION: The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02427386.

Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas / Potentiated estrogen in the homeopathic treatment of pelvic pain associated with endometriosis: a 24-week randomized, double-blind, placebo-controlled study

Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.

To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.

Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study.

OBJECTIVE: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). STUDY DESIGN: The present was a 24-week, randomized, double-blind, placebo-controlled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score≥5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). RESULTS: The EAPP global score (VAS: range 0 to 50) decreased by 12.82 (P<0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28; P<0.001), non-cyclic pelvic pain (2.71; P=0.009), and cyclic bowel pain (3.40; P<0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. CONCLUSIONS: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02427386.

Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study

OBJECTIVE: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). RESULTS: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p< 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p< 0.001), non-cyclic pelvic pain (2.71; p= 0.009), and cyclic bowel pain (3.40; p< 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. [...] CONCLUSIONS: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/show/NCT02427386.

Estrogênio potencializado no tratamento homeopático da dor pélvica associada à endometriose: Um estudo de 24 semanas, randomizado, duplocego e placebo-controlado / Estrogen potentiated in the homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study

Objetivo: Avaliar a eficácia e a segurança do estrogênio potencializado em comparação com o placebo no tratamento homeopático da dor pélvica associada à endometriose (DPAE). Desenho do estudo: Ensaio randomizado, duplo-cego e placebocontrolado de 24 semanas de duração, que incluiu 50 mulheres com idade entre 18-45 anos de idade, diagnóstico de endometriose infiltrativa profunda com base em ressonância magnética nuclear ou ultrassonografia transvaginal após preparo intestinal e escore ≥ 5 na escala analógica visual (EAV: intervalo de 0 a 10 pontos) para DPAE. Estrogênio potencializado (12cH, 18cH e 24cH) ou placebo foi administrado 2 vezes ao dia por via oral. A medida de desfecho primário foi a mudança na severidade da DPAE com base no escore global e parcial (EAV) entre as semanas 0-24, determinado pela diferença entre a pontuação média de 5 modalidades de dor pélvica crônica (dismenorreia, dispareunia de profundidade, dor pélvica acíclica, dor intestinal cíclica e/ou dor urinária cíclica). Os desfechos secundários foram: diferença nos escores médios para qualidade de vida (SF-36), sintomas de depressão (Inventário de Depressão de Beck, IDB) e sintomas de ansiedade (Inventário de Ansiedade de Beck, IAB). [...]O grupo placebo não mostrou qualquer melhora significativa nesses desfechos secundários. Esses resultados demonstraram a superioridade do estrogênio potencializado em comparação ao placebo. Alguns efeitos adversos foram associados com o estrogênio dinamizado. Conclusões: Estrogênio potencializado (12cH, 18cH e 24cH) na dose de 3 gotas 2 vezes ao dia durante 24 semanas foi significativamente mais eficaz que o placebo na redução da dor pélvica associada à endometriose.Registro do estudo: ClinicalTrials.gov Identificador: NCT02427386. (AU)

Objective: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). [...] Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: NCT02427386. (AU)fier: NCT02427386. (AU)

Potentized estrogen in homeopathic treatment of endometriosis-associatedpelvic pain: A 24-week, randomized, double-blind, placebo-controlled study

Objective: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p< 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p< 0.001), non-cyclic pelvic pain (2.71; p= 0.009), and cyclic bowel pain (3.40; p< 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. [...] Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/show/NCT02427386. (AU)

Estrogênio potencializado no tratamento homeopático da dor pélvica associada à endometriose: Um estudo de 24 semanas, randomizado, duplocego e placebo-controlado / Potentized estrogen in homeopathic treatment of endometriosis-associatedpelvic pain: A 24-week, randomized, double-blind, placebo-controlled study

Objetivo: Avaliar a eficácia e a segurança do estrogênio potencializado em comparação com o placebo no tratamento homeopático da dor pélvica associada à endometriose (DPAE). Desenho do estudo: Ensaio randomizado, duplo-cego e placebocontrolado de 24 semanas de duração, que incluiu 50 mulheres com idade entre 18-45 anos de idade, diagnóstico de endometriose infiltrativa profunda com base em ressonância magnética nuclear ou ultrassonografia transvaginal após preparo intestinal e escore ≥ 5 na escala analógica visual (EAV: intervalo de 0 a 10 pontos) para DPAE. Estrogênio potencializado (12cH, 18cH e 24cH) ou placebo foi administrado 2 vezes ao dia por via oral. A medida de desfecho primário foi a mudança na severidade da DPAE com base no escore global e parcial (EAV) entre as semanas 0-24, determinado pela diferença entre a pontuação média de 5 modalidades de dor pélvica crônica (dismenorreia, dispareunia de profundidade, dor pélvica acíclica, dor intestinal cíclica e/ou dor urinária cíclica). Os desfechos secundários foram: diferença nos escores médios para qualidade de vida (SF-36), sintomas de depressão (Inventário de Depressão de Beck, IDB) e sintomas de ansiedade (Inventário de Ansiedade de Beck, IAB). [...]O grupo placebo não mostrou qualquer melhora significativa nesses desfechos secundários. Esses resultados demonstraram a superioridade do estrogênio potencializado em comparação ao placebo. Alguns efeitos adversos foram associados com o estrogênio dinamizado. Conclusões: Estrogênio potencializado (12cH, 18cH e 24cH) na dose de 3 gotas 2 vezes ao dia durante 24 semanas foi significativamente mais eficaz que o placebo na redução da dor pélvica associada à endometriose.Registro do estudo: ClinicalTrials.gov Identificador: NCT02427386. (AU)

Conduta frente às malformações genitais uterinas: revisão baseada em evidências / Medical care for uterine genital malformations: evidence-based review

Este trabalho de revisão foi idealizado para analisar as malformações dos ductos de Müller, que, devido à sua frequência de 3 a 7,3% na população em geral, justificam uma análise mais profunda do tema. O objetivo foi avaliar, de acordo com a literatura por meio de metodologia adequada? Os aspectos mais relevantes dessas anomalias, com destaque para a etiopatogenia, classificação, diagnóstico e tratamento. Os resultados obtidos nesta revisão apontaram as melhores evidências, até o momento, de como conduzir as mulheres portadoras dessas malformações.

This review paper was organized in order to analyse Müllerian anomalies, because their frequency from 3 to 7,3% in people in general justify a better evaluation about these malformations. The objective of the study was to evaluate, according to literature - by a proper methodology - the main aspects of these malformations, with special attention to etiology, classification, diagnostic and treatment. The results of this review showed the best evidences up till now of how to manage women with these genital malformations.

Alternativas para o tratamento não hormonal de mulheres no climatério / Alternatives to non-hormonal treatment of climacteric women

Objetivo: Analisar as opções de tratamento não hormonal da mulher climatérica. Material e método: Estudo e análise dos trabalhos e capítulos de livro que mostrem avaliação adequada das opções de tratamento não hormonal das mulheres climatéricas, considerando as indicações, benefícios e tolerabilidade com os diferentes tratamentos. Resultados e conclusões: A revisão apresentou evidências de que medidas gerais (dieta, atividade física e ocupacional) são recomendáveis para todas as mulheres climatéricas. Para alívio dos sintomas vasomotores, o tratamento com mais índices de sucesso é realizado com antidepressivos, outras opções como cinarizina ou hipotensores podem beneficiar secundariamente as mulheres que devam utilizá-los por indicações clínicas. A fitoterapia, acupuntura e homeopatia ainda não apresentam evidências conclusivas...